- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02075788
Millet Products Study - Investigation of Glycemic Index and Satiety
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The purpose of this study is to investigate how millet incorporation into different baked product types (i.e. an extruded snack versus a biscuit) influences glycemic response and satiety.
This project will examine the effect of millet, on glycemic response and satiety. To determine the effect of product matrix and processing methods, testing will be done using an extruded snack, porridge, a couscous-like product and a biscuit.
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ontario
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Guelph, Ontario, Canada, N1G2W1
- Human Nutraceutical Research Unit, University of Guelph
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Men, age 19-40, non-smoking
- Normal fasting plasma glucose (<5.6 mmol/L but not below 3.6 mmol/L)
- Normal glucose tolerance (evaluated by a 75 g oral glucose test, i.e. <7.8 mmol/L but not below 3.6 mmol/L)
- BMI ranging from 18.5 to 29.9 kg/m2
Exclusion Criteria:
- Insulin resistance (IR) will be calculated from fasting glucose and insulin values using the Homeostasis Assessment Model 2 (HOMA2). A HOMA2-IR value of greater than 1.0 will be considered indicative of insulin resistance (Levy J.C. et al. 1998).
- Regular consumption of millet as defined by questionnaire at screening defined as more than 1x per week
- Smoking or use of recreational drugs
- Heavy alcohol use (defined as typically >14 drinks per week or >4 drinks on one occasion)
- Very low fibre consumption as assessed by 24 hour food diary and self-reported fruit/vegetable/whole grain servings.
- Restrained eater as defined by the questionnaire at screening (Three Factor Eating Questionnaire, Stunkard et al.,1985)
- Food neophobic defined by Food Neophobia Scale questionnaire
- Unusual sleep patterns or irregular breakfast consumption
- Recent (i.e. >4 kg in previous 3 months) or intended weight loss or gain
- Food allergies or any life-threatening allergy (food or otherwise)
- Inflammatory bowel disease or other gastrointestinal disorders
- Use of drugs which influence carbohydrate metabolism
- Training or elite athletes
- Inability to adhere to Study Protocols
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Commercial white bread
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
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Eksperimentel: Millet based products (porridge etc.)
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
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Aktiv komparator: Corn based products (porridge etc.)
All product servings will provide 50 g of available carbohydrate and will be consumed by participants within 10 minutes.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Determination of glycemic index based on collection of capillary plasma glucose
Tidsramme: Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes
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Outcome measures will be assessed at fasting, and postprandially at 15, 30, 45, 60, 90 and 120 minutes
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Self reported ratings of satiety
Tidsramme: Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours
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Outcome measures will be assessed at fasting, and postprandially every 30 minutes over 2 hours
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13AP004
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